Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

The incidence of coagulation abnormalities, total blood product transfusions and the incidence of organ injury and ventilator-associated pneumonia. [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of ventilator-associated pneumonia (VAP).

Secondary Outcome Measures:

Protocol violations, 28- and 60-day mortality, ventilator-free days and duration of ICU and hospital stay. [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Coagulation parameters are evaluated using standard functional tests (PT, PTT, fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. Mini bronchial lavage (mini-BAL) samples will be collected at 72 hours afer admission to the hospital and on any patient clinically suspected of VAP.

Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.

Dietary Supplement: Vitamin C

Other Name: ascorbic acid

Dietary Supplement: Vitamin E

Other Name: alpha-tocopherol

Placebo Comparator: 0.9% saline and sugar pill

100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.

Dietary Supplement: Saline (for Vitamin C)

0.9% saline administered to mimic Vitamin C

Drug: Placebo (for Vitamin E)

Sugar pill administered to mimic Vitamin E

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham Hospital

Blunt or penetrating injury

UAB highest trauma activation

Exclusion Criteria:

Age < 19 years of age

Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication

Patients with known liver disease

Minor patients

Pregnant patients (known or suspected pregnancy)

Patients who are incarcerated

Patients who lack a surrogate

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897792